Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Primary Purpose
Leg Length Inequality
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cell and RPR injection
Sponsored by
About this trial
This is an interventional treatment trial for Leg Length Inequality focused on measuring distraction, osteogenesis, limb length discrepancy, callus
Eligibility Criteria
Inclusion Criteria:
- both gender
- patient with limb-length discrepancy
- Age:18-65
Exclusion Criteria:
- Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
- Known allergic reaction to components of study treatment and/or study injection procedure
- Patients infected with hepatitis B,C or HIV
- pregnancy
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cell and RPR recepients
Arm Description
mesenchymal cells and plasma reach protein are injected to the callus center of short limb
Outcomes
Primary Outcome Measures
effect of mesenchymal cell transplantation to decrease limb inequal
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal
Secondary Outcome Measures
improve life quality
mesenchymal cells transplantation improve patients life quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01210950
Brief Title
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Official Title
Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.
Detailed Description
Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Inequality
Keywords
distraction, osteogenesis, limb length discrepancy, callus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cell and RPR recepients
Arm Type
Experimental
Arm Description
mesenchymal cells and plasma reach protein are injected to the callus center of short limb
Intervention Type
Biological
Intervention Name(s)
cell and RPR injection
Other Intervention Name(s)
cell therapy
Intervention Description
mesenchymal cells and Plasma reach Protein are injected to the callus center
Primary Outcome Measure Information:
Title
effect of mesenchymal cell transplantation to decrease limb inequal
Description
evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal
Time Frame
6 months
Secondary Outcome Measure Information:
Title
improve life quality
Description
mesenchymal cells transplantation improve patients life quality
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
both gender
patient with limb-length discrepancy
Age:18-65
Exclusion Criteria:
Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease
Known allergic reaction to components of study treatment and/or study injection procedure
Patients infected with hepatitis B,C or HIV
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
President of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad reza Baghban Eslami Nejad, PhD
Organizational Affiliation
Board scientific
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohssen Emadeddin, MD
Organizational Affiliation
Orthopadic Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Regenerative center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.royaninstitute.org
Description
Royan Institute
Learn more about this trial
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
We'll reach out to this number within 24 hrs